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New drug combo aims to outsmart Platinum-Resistant ovarian cancer

NCT ID NCT05198804

Disease control Sponsor: K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a new drug called ZN-c3 (azenosertib), either alone or combined with niraparib, in 117 women with ovarian cancer that no longer responds to platinum chemotherapy. The goal is to find safe doses and see if the drugs can shrink tumors. It is an early-stage trial, so while promising, it is not yet proven as a standard treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Azenosertib (ZN-c3) and niraparib
What this could lead to
If successful, this could provide a new treatment option for women with ovarian cancer that no longer responds to platinum-based chemotherapy.
What could go wrong
This is an early-phase trial (Phase 1/2) with only 117 participants, so results may not apply to all patients. The combination may cause side effects or fail to shrink tumors.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

117 people

The number who actually took part.

Started

Jan 2022

Finished

Jan 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: 1. Histologically or cytologically confirmed recurrent high grade epithelial ovarian, primary peritoneal, or fallopian tube cancer with histologic subtypes of serous, clear cell or endometroid for which there is no known or established treatment available with curative intent. 2. Subjects must have platinum-resistant disease. 3. Must have evaluable or measurable disease according to RECIST v1.1 criterion: defined as at least one lesion that can be accurately measured. 4. Adequate hematologic and organ function. 5. Ability and willingness to take oral medication. 6. Subjects must provide formalin-fixed, paraffin-embedded tumor samples available from the primary or recurrent cancer. Key Exclusion Criteria: 1. Prior therapy directed at the malignant tumor within the last four weeks prior to Cycle 1 Day 1 (6 weeks for nitrosoureas or mitomycin C). 2. A minimum of 10 days between termination of the prior PARPi and administration of ZN-c3 and niraparib treatment is required. 3. Any investigational drug therapy \<28 days. 4. Prior treatment with a WEE1 inhibitor. 5. Known hypersensitivity to any drugs similar to ZN-c3 and/or niraparib in class or its excipients. 6. Participant has any known history or current diagnosis of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML). 7. Uncontrolled hypertension (Diastolic BP \> 90 mmHg or Systolic BP \> 140 mmHg). 8. Myocardial impairment of any cause (e.g., cardiomyopathy, ischemic heart disease, significant valvular dysfunction, hypertensive heart disease, and congestive heart failure) resulting in heart failure by New York Heart Association Criteria (Class III or IV). 9. Significant gastrointestinal abnormalities, requirement for IV alimentation, active peptic ulcer, chronic diarrhea, or vomiting considered to be clinically significant in the judgment of the Investigator, or prior surgical procedures affecting absorption. 10. 12-lead ECG demonstrating a corrected QT interval using Fridericia's formula (QTcF) of \>480 ms, except for subjects with atrioventricular pacemakers or other conditions (e.g., right bundle branch block) that render the QT measurement invalid. 11. History or current evidence of congenital or family history of long QT syndrome or Torsades de Pointes (TdP). 12. Taking medications with a known risk of TdP (according to current information provided at https://crediblemeds.org).

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Conditions

The condition(s) this trial relates to.

fallopian tube cancer fallopian tube neoplasm ovarian cancer ovarian carcinoma primary peritoneal carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Fallopian tube cancer Ovarian cancer Platinum-resistant ovarian cancer Primary peritoneal carcinoma

Contacts and locations

Locations

  • Arizona Oncology Associates (Wilmot HOPE) - USOR

    Tucson, Arizona, 85711, United States

  • Centre Georges François Leclerc

    Dijon, France

  • Centre Hospitalier Lyon Sud

    Saint-Genis-Laval, France

  • Centre Oscar Lambret

    Lille, France

  • EDOG - Institut Claudius Regaud

    Toulouse, France

  • ICANS - Institut de cancérologie Strasbourg Europe

    Strasbourg, France

  • Institut Gustave Roussy

    Villejuif, France

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201, United States

  • MD Anderson Cancer Center, Gynecologic Oncology Center

    Texas City, Texas, 77030, United States

  • Mount Sinai Comprehensive Cancer Center

    Miami Beach, Florida, 33140, United States

  • Optimum Clinical Research Group- Women's Oncology

    Albuquerque, New Mexico, 87109, United States

  • Rocky Mountain Cancer Centers

    Aurora, Colorado, 80012, United States

  • Rutgers New Jersey Medical School

    Newark, New Jersey, 07103, United States

  • Spectrum Health System

    Grand Rapids, Michigan, 49503, United States

  • Texas Oncology-Fort Worth Cancer Center

    Fort Worth, Texas, 76104, United States

  • The Blavatnik Family - Chelsea Medical Center at Mount Sinai

    New York, New York, 10011, United States

  • University of Colorado

    Aurora, Colorado, 80045, United States

  • University of Virginia

    Charlottesville, Virginia, 22908, United States

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031, United States

  • Virginia Commonwealth University

    Richmond, Virginia, 23298, United States

  • Willamette Valley Cancer Institute and Research Center

    Eugene, Oregon, 97401, United States

  • Women and Infants Hospital of Rhode Island

    Providence, Rhode Island, 02905, United States

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